Herpes Simplex Labialis on the perioral area MedDRA version: 9.1 Level: LLT Classification code 10019948 Term: Herpes simplex
Conditions
Interventions
Product Name: Acyclovir Liquipatch
Product Code: MI-LP-01
Pharmaceutical Form: Gel
INN or Proposed INN: Aciclovir
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentrat
Sponsors
MIPHARM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained, 2. Patients of either sex aged > 18 and ≤ 70 years; 3. Patients in good general health conditions; 4. Patients with recurrent Herpes Simplex labialis infections; 5. Patients with clinically diagnosed Herpes Simplex labialis on the perioral area and burning symptoms started ≤ 24 hours; 6. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) and must be willing to continue using it throughout the entire study period; 7. Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit; 8. Patient?s co-operative attitude and able to understand and adhere to study protocol procedures and timelines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with diseases requiring systemic or topical corticosteroids; 2. Concomitant use of other anti-herpetic/antiviral drugs; 3. Concomitant use of anti-inflammatory medications or analgesics; 4. Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions; 5. Immunocompromised patients; 6. Patients with herpetic stomatitis (first infection); 7. Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares; 8. Patients with lesions wider than 2.0 cm2; 9. Traumatic loss of first crust; 10. Patients affected by severe renal, dysmetabolic or hepatic failure, which represent a risk to the subjects; 11. Presence of underlying medical conditions that might interfere with study completion; 12. Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients; 13. History of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements; 14. Breastfeeding females; 15. Necessity to have a concomitant therapy with any drug mentioned in the restrictions. 16. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 17. Patients who received any investigational drug within the last 12 weeks; 18. Patients who have been previously enrolled in this study; 19. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that the new topical formulation of acyclovir 5% gel (Acyclovir Liquipatch) is more effective than the acyclovir 5% cream formulation in time to healing of lesions of Herpes Simplex Labialis.;Secondary Objective: The secondary objectives of the study are: To assess the efficacy of the two investigational medicinal products (IMPs) on extension of lesions, staging of lesions, and intensity of itching; To assess the local tolerability and general safety of the two IMPs.;Primary end point(s): Time to healing, defined as the rate of patients with complete non-traumatic loss of the first hard crust (residual erythema can be present after loss of hard crust) at any follow-up visit, as assessed by the ?external observer?. | — |
Countries
Italy
Outcome results
None listed